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Completed

NCT Number: NCT01925664

Doula Support for Young Mothers: A Randomized Trial

The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.

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Key information

Age range

14 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

The goal of this study is to evaluate a doula home visiting model -- sometimes called the "community doula model." This model differs from typical hospital based doula interventions in several ways. Doulas are providers from the same community backgrounds as their clients. Services are not just provided during labor and delivery, but throughout the final trimester and during the first weeks after delivery. Prenatal and postpartum services are provided in the homes of the mothers. The model was developed specifically for working with low-income mothers and with young mothers.

A two-armed randomized controlled trial was conducted at the University of Chicago Hospitals. Participants were recruited through two out-patient obstetric clinics affiliated with the Hospitals. The clinics primarily served a low-income, African-American population, reflective of the families in the communities near to the hospital. The study was open to all young women receiving prenatal care at the clinics who met age and eligibility criteria. After providing informed consent and completing a baseline interview, participants were randomized into two groups. The experimental group, in addition to receiving regular clinical care, received weekly home visiting services from a doula and the support of a doula at the hospital during labor and delivery. Doulas worked with their clients until three months postpartum. The control group received standard clinical care and had access to social work case management.

Four paraprofessional doulas delivered the study intervention. Before providing study services, doulas had been trained to provide childbirth education, labor support, breastfeeding education, and parent-child interaction support.

Followup research assessments of the doula and control group mothers and infants were conducted during the first three days postpartum, at 4 months postpartum, at 12 months postpartum, and at 24 months postpartum. 80% of the sample was retained through the 24 month followup assessment. Follow up assessments involved interviews with the mothers, videotaping of mother-infant interaction, and behavioral assessment of the infants. Obstetric and newborn hospital medical charts were also reviewed.

The study evaluated outcomes that have been the focus of prior studies of hospital-only doula services: use of obstetrical intervention in labor and delivery (anesthesia, surgical delivery), mother labor efficacy, breastfeeding, and maternal depression. A major contribution of this study is to explore longer term outcomes not evaluated in prior studies of doula intervention, particularly parenting and child development outcomes. The study evaluated multiple dimensions of parenting including parenting behavior (sensitivity, stimulation), parenting efficacy, parenting attitudes, and parenting stress. Child development outcomes included cognitive development and early behavior problems.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant and less than 34 weeks gestation
  • planning to deliver at study hospital
  • between ages 14 and 21

Exclusion criteria

  • planning to move out of community after giving birth
  • planning to give up custody of infant
  • prior c-section delivery

Treatment and study plan

Doula

Behavioral

This intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling.

Primary outcomes

  1. Breastfeeding Initiation

    Time frame: Three days postpartum

  2. Positive parenting behavior (Parent Child Observation Guide)

    Time frame: 4 months postpartum

    Videotaped interactions between mothers and infants coded by masked observers

Secondary outcomes

  1. Breastfeeding duration

    Time frame: 4- and 12 months postpartum

  2. Positive parenting behaviors (Parent Child Observation Guide)

    Time frame: 12- and 24 months postpartum

    Videotaped interactions between mothers and infants coded by masked observers

  3. Use of labor anesthesia

    Time frame: Start of labor through childbirth

  4. Labour Agentry Scale

    Time frame: 1 day postpartum

    The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor

  5. Adult Adolescent Parenting Inventory (AAPI)

    Time frame: 4 months postpartum

    The AAPI is a self report scale that measures appropriate parenting attitudes

  6. Maternal Self-Efficacy Scale

    Time frame: 4-, 12-, and 24 months postpartum

    The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.

  7. Parenting Stress Index (PSI)

    Time frame: 4-, 12-, and 24 months postpartum

    The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 4-, 12-, and 24 months postpartum

    The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.

  9. Timing of solid food introduction to infant

    Time frame: 4- and 12 months postpartum

  10. The Brief Infant Toddler Social Emotional Assessment (BITSEA)

    Time frame: 12- and 24 months postpartum

    The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.

  11. Mullen Scales of Early Learning

    Time frame: 24 months postpartum

    The Mullen is an assessment tool that measures child motor, cognitive, and language development. Trained assessors administered the instrument to the toddlers of study mothers.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Aug 20, 2013
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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